Effects of an Anal Insert Device in Fecal Incontinence

Inclusion Criteria

• Able to provide signed (written) informed consent
• Diagnosis of fecal incontinence, with duration of symptoms six months or longer with a history of at least one fecal incontinence (FI) episode per week or at least four episodes per month
• Subject comprehends study meaning and is capable of carrying out study duties
• Patient is fluent in English as study questionnaires have been validated using English
• If female and of childbearing potential, patient has had a negative urine pregnancy test within 21 days of the first day of the baseline visit
• If applicable, patient agrees to use acceptable birth control (surgical sterilization, abstinence, approved hormonal contraceptives such as birth control pills, barrier methods such as condom or diaphragm used with a spermicide, or an intrauterine device (IUD)). If not applicable, the reason why shall be documented on the screening log.
• Subject is at least 18 years of age at time of consent
• Patients has failed conservative medical therapy (i.e., the use of bulking agents, anti-diarrheal agents (e.g., loperamide) and biofeedback therapy as appropriate) for Fecal Incontinence

Exclusion Criteria

• Unable or unwilling to provide informed consent or to comply with study procedures
• History of anorectal pathology in the past 6 months (perianal abscess or fistula, fecal impaction, or clinically significant rectocele).
• History of inflammatory bowel disease with active proctosigmoiditis
• History of rectal surgery in past 6 months where the Investigator determines that the use of the study device may be associated with an increased risk of complications.
• History of acute or chronic illness or history of illness or any other reason which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, etc. The reason for exclusion of any enrolled subject shall be documented on the screening log.
• Patient has known clinically-significant immune deficiency state (e.g., HIV infection).
• Patient is taking drugs with a low therapeutic index, such as warfarin, digoxin, and anti-seizure medications
• If patient has clinically suspected upper or lower gastrointestinal (GI) obstruction, they must be excluded or have been evaluated per standard of care and obstruction ruled out before screening. Determination of obstruction shall be documented on the screening log.
• History of fecal impaction with overflow diarrhea in the past 6 months
• History of Ileo-anal pouch
• History of allergy to silicone or one of its components
• Patient is pregnant and/or nursing
• Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
• Patient whom, after training from a healthcare provider, cannot insert or expel the device themself or with assistance from a caregiver
• History of anal or rectal pain and/or rectal bleeding in the past month
• Subject cannot retain either device (10 or 13 mm) while ambulating at the screening visit
• Post baseline anoscopy examination, presence of an anal fissure, Grade III-IV internal hemorrhoids, or thrombosed external hemorrhoids.

In addition, subjects will not be eligible to participate in the Treatment Period if during the baseline period or at the anorectal manometry visit:

• Used rescue medications beyond those allowed by the protocol
• demonstrated lack of compliance (for e.g., did not complete bowel diaries for 3 days in any week during the baseline diary period).